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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020829
Receipt No. R000022370
Scientific Title Desensitization therapy for preexisted anti-HLA antibody with anti-CD20 Antibody, plasma exchange, and immunoglobulin in kidney transplantation
Date of disclosure of the study information 2016/02/01
Last modified on 2019/08/05

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Basic information
Public title Desensitization therapy for preexisted anti-HLA antibody with anti-CD20 Antibody, plasma exchange, and immunoglobulin in kidney transplantation
Acronym desensitization therapy for preexisted anti-HLA antibody
Scientific Title Desensitization therapy for preexisted anti-HLA antibody with anti-CD20 Antibody, plasma exchange, and immunoglobulin in kidney transplantation
Scientific Title:Acronym desensitization therapy for preexisted anti-HLA antibody
Region
Japan

Condition
Condition kidney transplantation recipients with preexisted anti-HLA antibody
Classification by specialty
Nephrology Urology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm a safety of desensitization therapy, including rituximab administration, for kidney transplantation recipients with HLA-Donor specific antibody positive.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes graft failure rate
Key secondary outcomes patient survival rate
rate of allograft rejection
adverse effect rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Rituximab administration
single dose administration of 200mg/body before renal transplantation
Plasma exchange
three to four times replaced by albumin
Immunoglobulin administration
IVIG 2-3g/kg when donor specific antibody is high MFI (>3000)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Kidney transplantation recipients with HLA-donor specific antibody at Division of Nephrology and hypertension, department of internal medicine, and Urology, The Jikei University of Medicine.

2)The patient who can have a decision about the participation of this study voluntary, and understand consent brief and other explanation documents.
Key exclusion criteria 1) The patients with serious hypersensitivity or medical history of anaphylaxis for the products derived from mouse protein, Rituximab, immunoglobulin, and an integrent of the albumin to prepare plasma exchange.
2) The patients whom the medical attendant judged when the exacerbation of the sign exceeded benefit of Rituximab among them who have severe infectious diseases, a cardiac dysfunction, respiratory diseases, or a bone marrow dysfunction.
3) The patients with an medical history of the drug hypersensitivity and the allergic to albumin (preparation for plasma exchange), Rituximab or immunoglobulin whom the medical attendant judged when these adverse effects exceeded the benefits of these medications.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Yokoo
Organization The Jikei University of Medicine
Division name Division of Nephrology and Hypertension, Department of Internal Medicine
Zip code 105-8461
Address Minato-ku, Tokyo
TEL +81-3-3433-1111
Email nakadaya@jikei.ac.jp

Public contact
Name of contact person
1st name Yasuyuki
Middle name
Last name Nakada
Organization The Jikei University of Medicine
Division name Division of Nephrology and Hypertension, Department of Internal Medicine
Zip code 105-8461
Address 3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo
TEL +81-3-3433-1111
Homepage URL
Email tyokoo@jikei.ac.jp

Sponsor
Institute Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University of Medicine
Institute
Department

Funding Source
Organization Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Division of Hypertension and Nephrology, Department of Internal Medicine, The Jikei University School of Medicine
Address 3-25-8, Nishi-shimbashi, Minato-ku, Tokyo
Tel +81334331111
Email nakadaya@jikei.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 01 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022370

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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